Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04521595
Collaborator
(none)
17
1
1
11.5
1.5

Study Details

Study Description

Brief Summary

There has been a steep rise in the prevalence of obesity among children and adults in the United States. The Weigh Smart program, a family based weight management program was developed in 2005 with significant improvement in the severity of obesity among children in the Baltimore are participating in the group program with limited impact outside the region due to transportation. Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street on the Eastern Shore and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit- steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. Investigators plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit re: sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weigh Smart Telehealth intervention
N/A

Detailed Description

. Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street to families of overweight and obese children between 7-17 years of age referred from selected pediatric practices on the Eastern Shore of Maryland and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit charge 3- steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. Investigators plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit charge 3 sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth
Actual Study Start Date :
Aug 11, 2020
Actual Primary Completion Date :
Jul 26, 2021
Actual Study Completion Date :
Jul 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: weigh smart intervention

open treatment arm to receive group based lifestyle intervention via telehealth.

Behavioral: Weigh Smart Telehealth intervention
Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street on the Eastern Shore and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit - steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. We plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

Outcome Measures

Primary Outcome Measures

  1. Combined Weight change in parent and child [Up to 12 months]

    Comparison of combined weight of both child and parent at baseline to weight at 1,3,6 months post-intervention

Secondary Outcome Measures

  1. Change in Pediatric Sleep Questionnaire (PSQ) sleep questionnaire in child [up to 12 months]

    This will assess the comparison of score at baseline to 3-6 months post-intervention. The PSQ contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric Obstructive Sleep Apnea features. It is a binary scale of 2 responses, YES=1 OR NO=0, therefore a maximum of 22 points and minimum of zero.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

  • Children who are overweight/obese (7-17 years of age)

  • Children must be referred by selected Maryland Eastern Shore and Western Maryland pediatric practices to Mount Washington Pediatric Hospital Weigh Smart. Families must provide informed consent at the weigh smart visit and have access to either a tablet, laptop or smart phone device to participate.

Exclusion Criteria

  • Children outside of the age range

  • Children not seen by Maryland Eastern Shore or Western Maryland pediatric providers who are part of the intervention group

  • Children who do not have internet access either by smart phone or tablet to allow telehealth participation

  • Children who are unwilling to participate in group program and followup local visits

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Washington Pediatric Hospital Baltimore Maryland United States 21209

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04521595
Other Study ID Numbers:
  • IRB00251530
First Posted:
Aug 20, 2020
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021